MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-01-090
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient had elevated metal ion.Revision notes stated that scar excision was performed including removal of abnormal appearing tissue.A minimal sized fluid collection was evacuated.There was some evidence of corrosion at the trunnion.There was near impingement with extension and external rotation of the hip.The cup was too anteverted and vertical.Leg lengths looked short.Cup, head.And sleeve were removed.Operative findings stated that a local soft tissue response and fluid collection in line with an adverse metal on metal reaction was found.There are some contained boney defects on the acetabular side that was bone grafted.There was also some posterior superior bone loss and medial.The local soft tissues were stained in a way that is characteristic for a metal on metal failure.Added patient's dob, medical history, and laboratory data.Corrected patient's initials.Added head, sleeve, and stem due to elevated metal ion reported.Added date of implantation.Doi: (b)(6) 2006 - dor: (b)(6) 2020 (left hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5 and h6 (patient).
Event or Problem Description
Patient experienced discomfort, managed socks/shoes with some difficulty.Patient has enlarging supra- acetabular cyst which could be related to metal-on-metal failure.

• Brand Name: SUMMIT POR TAPER SZ3 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12189706
• Report Number: 1818910-2021-15454
• Device Sequence Number: 3802131
• Product Code: LPH
• UDI-Device Identifier: 10603295059349
• UDI-Public: 10603295059349
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1570-01-090
• Device Catalogue Number: 157001090
• Device Lot Number: A1PGG1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 09/28/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/06/2021; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR